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Drug

Sotatercept

Approved · EMA
Emerging researchLate-stage developmentCooling momentum

Also known as (HUMAN ACTIVIN RECEPTOR TYPE-2A PRECURSOR-(21-135)-PEPTIDYL)-THREONYLTRIGLYCYL-(HUMAN IMMUNOGLOBULIN HEAVY CONSTANT .GAMMA.1 FC FRAGMENT: (8-15)-HINGE-(A-100>V)-CH2-CH3 OF HOMO SAPIENS IGHG1*03), (123-123':126-126')-BISDISULFIDE DIMER, (HUMAN ACTIVIN RECEPTOR TYPE-2A PRECURSOR-(21-135)-PEPTIDYL)-THREONYLTRIGLYCYL-(HUMAN IMMUNOGLOBULIN HEAVY CONSTANT .GAMMA.1 FC FRAGMENT: (8-15)-HINGE-(A-100>V)-CH2-CH3 OF HOMO SAPIENS IGHG1*03), (123-123':126-126')-BISDISULPHIDE DIMER, Winrevair, ACTIVIN RECEPTOR TYPE IIA (SYNTHETIC HUMAN EXTRACELLULAR DOMAIN-CONTAINING FRAGMENT) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN HEAVY CHAIN FC FRAGMENT), DIMER.

RxNorm2678930UNII0QI90BTJ37
5
Research papers
11
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2, Multicenter, Open-label Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) With Heart Failure With Preserved Ejection Fraction (HFpEF)

Clinical trial2026-07-22Results expected Q3 2035 · ClinicalTrials.gov

A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)

Clinical trial2026-07-09Results expected Q1 2029 · ClinicalTrials.gov

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Clinical trial2026-07-09Results expected Q4 2028 · ClinicalTrials.gov

A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India

Clinical trial2026-06-29Results expected Q2 2028 · ClinicalTrials.gov

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.

Clinical trial2026-06-15Results expected Q2 2029 · ClinicalTrials.gov

A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension (PAH)

Clinical trial2026-06-10Results posted · ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality

Clinical trial2026-05-29Results posted · ClinicalTrials.gov

Phase 3, Open-Label Multicenter Study of Sotatercept in Japanese Participants With Pulmonary Arterial Hypertension.

Research2026-01-31JACC. Asia

Sotatercept in Patients with Pulmonary Arterial Hypertension at High Risk for Death.

Research2025-03-31The New England journal of medicine

Approval: Winrevair (EMA)

Regulatory2024-08-22EMA

SPECTRA Phase 2b Study: Impact of Sotatercept on Exercise Tolerance and Right Ventricular Function in Pulmonary Arterial Hypertension.

Research2024-04-04Circulation. Heart failure

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension.

Research2023-03-06The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sotatercept
Aliases & brands
(HUMAN ACTIVIN RECEPTOR TYPE-2A PRECURSOR-(21-135)-PEPTIDYL)-THREONYLTRIGLYCYL-(HUMAN IMMUNOGLOBULIN HEAVY CONSTANT .GAMMA.1 FC FRAGMENT: (8-15)-HINGE-(A-100>V)-CH2-CH3 OF HOMO SAPIENS IGHG1*03), (123-123':126-126')-BISDISULFIDE DIMER(HUMAN ACTIVIN RECEPTOR TYPE-2A PRECURSOR-(21-135)-PEPTIDYL)-THREONYLTRIGLYCYL-(HUMAN IMMUNOGLOBULIN HEAVY CONSTANT .GAMMA.1 FC FRAGMENT: (8-15)-HINGE-(A-100>V)-CH2-CH3 OF HOMO SAPIENS IGHG1*03), (123-123':126-126')-BISDISULPHIDE DIMERWinrevairACTIVIN RECEPTOR TYPE IIA (SYNTHETIC HUMAN EXTRACELLULAR DOMAIN-CONTAINING FRAGMENT) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN HEAVY CHAIN FC FRAGMENT), DIMER
RxNorm CUI
2678930
UNII
0QI90BTJ37
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-08-22
Latest approval
2024-08-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-08-22Approval
Approval: Winrevair (EMA)
Indication: Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II,… Show full indication

Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

31 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
31
registered trials across all phases
LATEST COMPLETION 2026
11
Active studies
9
Recruiting
10
Late-stage (III+)
13
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 31
Phase 12Phase 1 / 21Phase 218Phase 35Phase 45

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)

RecruitingPH IVUniversity of Albertan=272030

An Open-label, Randomized, Controlled Trial to Evaluate the Efficacy of Sotatercept Add-on Therapy Compared to Standard PAH Therapy With Pulmonary Vasodilators for Pulmonary Arterial Hypertension Associated With Pulmonary Vasodilator-resistant, Unrepaired Congenital Shunts (ASD, VSD, PDA) Including Eisenmenger Syndrome：SuMILE Trial

RecruitingPH IVKazuya Hosokawan=362028

A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India

Not yet recruitingPH IVMerck Sharp & Dohme LLCn=302028

RECOMPENSE: Right vEntricular COMPENsation With SotatercEpt: a Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension

RecruitingPH IVAmsterdam UMC, location VUmcn=202026

Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

CompletedPH IVMayo Clinicn=302026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

CompletedPH IVMayo Clinicn=302026

A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation

CompletedPH IMerck Sharp & Dohme LLCn=1462025

A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

CompletedPH IIMerck Sharp & Dohme LLCn=1642025

A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension (PAH)

CompletedPH IIIMerck Sharp & Dohme LLCn=462025

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality

CompletedPH IIIAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAn=1732025

A Single-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Chinese Participants

CompletedPH IMerck Sharp & Dohme LLCn=242024

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20232026
Major research themes4
Pulmonary Arterial Hypertension4Recombinant Fusion Proteins2Exercise Tolerance1Ventricular Function, Right1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
  • Circulation. Heart failure1
  • JACC. Asia1
  • The European respiratory journal1
Leading researchers
  • Waxman AB4
  • Badesch DB3
  • de Oliveira Pena J3
  • Ghofrani HA3
  • Gibbs JSR3
  • Gomberg-Maitland M3
  • Hoeper MM3
  • Humbert M3
Leading institutions
free-text, unnormalised
  • Brigham and Women's Hospital2
  • George Washington University School of Medicine and Health Sciences2
  • Hannover Medical School2
  • National Heart and Lung Institute2
  • Université Paris-Saclay2
  • University of Colorado2
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.